| CTRI Number |
CTRI/2025/06/089289 [Registered on: 23/06/2025] Trial Registered Prospectively |
| Last Modified On: |
18/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To Evaluate The Efficacy Of Vidangadi Nasya In Ardhavabhedak W.S.R To Migraine |
|
Scientific Title of Study
|
Randomized Open Controlled Clinical Study To Evaluate The Efficacy Of Vidangadi Nasya In Ardhavabhedak W.S.R To Migraine |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Dimpal Ravindra Bhadane |
| Designation |
PG Scholar |
| Affiliation |
Yashwant Ayurvedic College Post Graduate Training And Research Centre |
| Address |
Yashwant Ayurvedic College Post Graduate Training And Research Centre Panchakarma Department OPD Kodoli Kolhapur MAHARASHTRA 416114
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
8408049186 |
| Fax |
|
| Email |
dimpalbhadane0406@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vidyanand Thorwat |
| Designation |
Professor |
| Affiliation |
Yashwant Ayurvedic College Post Graduate Training And Research Centre |
| Address |
Yashwant Ayurvedic College Post Graduate Training And Research Centre Panchakarma Department OPD Kodoli Kolhapur MAHARASHTRA 416114
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9011081819 |
| Fax |
|
| Email |
vidyanandthorwat@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vidyanand Thorwat |
| Designation |
Professor |
| Affiliation |
Yashwant Ayurvedic College Post Graduate Training And Research Centre |
| Address |
Yashwant Ayurvedic College Post Graduate Training And Research Centre Panchakarma Department OPD Kodoli Kolhapur MAHARASHTRA 416114
MAHARASHTRA
416114
India |
| Phone |
9011081819 |
| Fax |
|
| Email |
vidyanandthorwat@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Yashwant Ayurvedic College Post Graduate Training And Research Centre Kodoli Tal Panhala Dist kolhapur 416114 |
|
|
Primary Sponsor
|
| Name |
Dr Dimpal Ravindra Bhadane |
| Address |
Panchakarma Department Yashwant Ayurvedic College Post Graduate Training And Research Centre Kodoli Tal Panhala Dist Kolhapur 416114 |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Dimpal Ravindra Bhadane |
Yashwant Dharmartha Rugnalaya Kodoli |
Panchakarma Department OPD Yashwant Ayurvedic College Post Graduate Training And Research Centre kodoli Tal Panhala Dist Kolhapur 416114
Kolhapur
MAHARASHTRA |
8408049186
dimpalbhadane0406@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:G430||Migraine without aura. Ayurveda Condition: ARDHAVABEDAKAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | nasyam/ nastam, नस्यम्/ नस्तम् | (Procedure Reference: yogaratnakar, Procedure details: Bhrungrajadi nasya yoga will be taken in a small plastic bottle fitted with dropper Dropper will be held in right hand & with the help of left index finger nasal septum will be slightly elevated to create a straight passage within the vestibule with the help of dropper 8 drops of Bhrungrajadi nasya yoga will be instilled into each nostril With the help of left thumb left nostril will be closed There after patient will be asked to inhale deeply The patient should remain relaxed while taking nasya He should avoid speech anger sneezing laughing and head shaking during nasya karma)
(1) Medicine Name: Bhrugrajadi nasya, Reference: yogaratnakar shirorog chikitsa , Route: Nasal, Dosage Form: Kalka/ Paste, Dose: 8(drops), Frequency: od, Duration: 3 Months | | 2 | Intervention Arm | Procedure | - | nasyam/ nastam, नस्यम्/ नस्तम् | (Procedure Reference: yogaratnakar shirorog chikitsa , Procedure details: Vidangadi nasya yoga will be taken in a small plastic bottle fitted with dropper Dropper will be held in right hand & with the help of left index finger nasal septum will be slightly elevated to create a straight passage within the vestibule with the help of dropper 8 drops of vidangadi nasya yoga will be instilled into each nostril With the help of left thumb left nostril will be closed There after patient will be asked to inhale deeply The patient should remain relaxed while taking nasya He should avoid speech anger sneezing laughing & head shaking during nasya karma)
(1) Medicine Name: Vidangadi nasya , Reference: yogaratnakar , Route: Nasal, Dosage Form: Kalka/ Paste, Dose: 8(drops), Frequency: od, Duration: 3 Months |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient presenting signs and symptoms of ardhavabhedak like attack of headache mostly unilateral in nature variable in intensity frequency and duration with or without nausea
Patient will be selected irrespective of gender religion or occupation
Patient age between 18 years to 60 years
Patient willing to give inform consent and able to participate in study
Patient fit for nasya karma |
|
| ExclusionCriteria |
| Details |
Patient having severe systemic diseases like HTN DM Asthma
Women who is under menstrual cycle
Pregnant and lactating women |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the efficacy of Vidangadi nasya in Ardhavabhedak W.S.R. to migraine |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To reduce signs & symptoms of Ardhavabhedak
To assess improvement by signs symptoms & gradation of assessment criteria
To study etiopathology clinical manifastation of ardhavabhedak
To improve quality of life & reduce discomfort of patient
|
3 months |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/07/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
To study the efficacy of Vidangadi nasya in Ardhavabhedak w.s.r. to migraine .Study will be carried out in OPD of Panchakarma department of Yashwant Ayurvedic College and hospital kodoli, kolhapur. this observation would be drawn on the basis of symptoms after treatment given . |